K935343 is an FDA 510(k) clearance for the CENTRIFIQ BLOOD CONTROL. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).
Submitted by Hematronix, Inc. (Plano, US). The FDA issued a Cleared decision on January 27, 1994, 128 days after receiving the submission on September 21, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K935343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1993 |
| Decision Date | January 27, 1994 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JPK — Mixture, Hematology Quality Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |